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Assessment of Artesunate/Mefloquine in the Peruvian Amazon

NCT02084602 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2021-04-29

No results posted yet for this study

Summary

There is growing evidence of the emergence of P. falciparum resistance to artesunate (a derivative of artemisin) in Southeast Asia. The emergence and spread of resistant strains to artemisinin would represent an alarming threat to the success of the antimalarial combination therapy in the region. The delayed clearance of parasitemia for more than 24 hours has been taken as an early sign of resistance, a phenomenon seen at the Thai-Cambodia border.

The purpose of this research study, is to assess the in vitro and in vivo efficacy of combinated artesunate/mefloquine therapy to treatment of uncomplicated Plasmodium falciparum malaria in the Peruvian Amazon through the analysis of the rate of clearance of parasitemia and other important outcomes.

Conditions

  • Malaria, Falciparum

Interventions

DRUG

Artesunate

Orally administration of artesunate 4mg/Kg by three days

DRUG

Mefloquine

Orally administration of mefloquine 15mg/Kg in the fourth day Orally administration of mefloquine 10mg/Kg in the fifth day

Sponsors & Collaborators

  • U.S. Naval Medical Research Unit No.6 (NAMRU-6)

    collaborator UNKNOWN

  • Instituto Nacional de Salud. Peru

    lead OTHER_GOV

Principal Investigators

  • Salomon Durand, Master · NAMRU 6

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-18
Primary Completion
2015-11-06
Completion
2016-04-13

Countries

  • Peru

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02084602 on ClinicalTrials.gov